E TEST STRIPS INSTRUCTIONS FOR USE
Contents 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Intended Use ...........................................................................3 Before You Get Started ............................................................4 Contents of the Accu-Chek Active Test Strip Box ....................6 Additional Materials Required for Blood Glucose Testing .........7 Blood Volume and Test Time ...................................................8 Storing and Using Test Strips Properly ...............................
1 Intended Use The Accu-Chek Active test strips (test strips) are intended to be used with the Accu-Chek SugarView app (hereinafter called app) and the Accu-Chek SugarView color card to perform a digital visual check of the blood glucose range. Once a capillary blood sample has been applied to the test area of the test strip, the app interprets the color change and a semi-quantitative blood glucose range appears on the smartphone display. The test strips may only be used outside of the body.
2 Before You Get Started Read these instructions for use before testing your blood glucose with the Accu-Chek SugarView app and the Accu-Chek Active test strips. The User’s Manual of the Accu-Chek SugarView app contains all the information you need to perform a test and to understand your test results. If you have questions, contact customer support. Contact information for your country can be found in the main menu. Open the app, and go to: PROFILE > Support Information > Support Contact.
2 Before You Get Started The User’s Manual of the Accu-Chek SugarView app includes details on where to get information on the effects and prevalence of diabetes. W WARNING Risk of suffocation This product contains small parts that can be swallowed. Keep the small parts away from small children and people who might swallow small parts.
3 Contents of the Accu-Chek Active Test Strip Box • 1 or 2 containers with test strips; on the container label is a color chart, the concentration table for the control solutions and the code number • 1 package insert inside the test strip box* *The package insert refers only to the use of the test strips with a blood glucose meter. For information on how to use the test strips with the app, open the app and go to: PROFILE > Support Information > Test Strip Instructions.
4 Additional Materials Required for Blood Glucose Testing • The Accu-Chek SugarView app and User’s Manual (available in the app) • Finger pricker and lancets • Accu-Chek SugarView color card 7
5 Blood Volume and Test Time The test strip requires 1–2 μL of blood (1 µL (microliter) = 1 thousandth of a milliliter) per blood glucose test. The blood glucose test takes approximately 13–45 seconds.
6 Storing and Using Test Strips Properly W WARNING Risk of a serious health incident If the test strips are not stored or used properly, they can deliver incorrect test results. This can lead to a serious health incident. • Store the test strips at temperatures between +2 and +30 °C in a dry place away from direct sunlight. Also note the following instructions: • The drying agent contained in the cap of the test strip container protects the test strips from moisture.
7 Test Principle On each test strip there is a test area containing reagents. When blood is applied to the test area, the glucose dehydrogenase enzyme (Mut. Q-GDH 2) reacts with the blood glucose. The subsequent chemical reaction changes the color of the test area. The app performs a digital visual test of the color of the control window, interprets the color change on the test strip using the standard color information provided by the accessory color card.
8 Blood Glucose Ranges mg/dL mmol/L Description greater than 600 greater than 33.4 outside the measuring range, blood glucose cannot be properly detected 301 to 600 16.7 to 33.4 very high, exercise and doctor visit recommended 181 to 300 10.0 to 16.7 high, exercise recommended 131 to 180 7.3 to 10.0 after a meal (within 2 hours): within target range, good blood glucose result before meal or fasting: slightly high blood glucose result, exercise recommended 71 to 130 3.9 to 7.
9 Checking the Test Result Check by Color Comparison The test strip itself allows you to estimate the test result through color comparison and thus check the displayed test result in addition. The color comparison serves only as a plausibility check of the test result. • Before the test: On the back of the test strip, there is a round, colored control window. Compare the color of this window with the colored dots on the label of the test strip container.
10 Performance Characteristics For performance characteristics of the app in combination with test strips refer to the Accu-Chek SugarView app User’s Manual. Go to PROFILE > Support Information > App Manual.
11 Limitations Certain health conditions can lead to an incorrect test result. If you know that one or more of the following health conditions apply to you, do not use the test strip. If you are unsure whether any of the health conditions apply to you, contact your healthcare professional. • Intravenous administration of ascorbic acid may lead to falsely elevated test results. Concentrations of ascorbic acid in the blood greater than 8 mg/dL (greater than 0.
12 Reagent Composition Minimum content per cm2 at time of manufacture Mutant variant of quinoprotein glucose dehydrogenase (Mut. Q-GDH 2, modified variant of EC 1.1.5.2), acinetobacter spec. 3.0 U Pyrroloquinoline quinone 0.2 μg Bis-(2-hydroxyethyl)-(4-hydroximinocyclohexa-2,5dienylidene)-ammonium chloride 7.9 μg 2,18-phosphomolybdic acid, sodium salt 85 μg Stabilizer 0.13 mg Non-reactive ingredients 1.
13 Discarding the Test Strip W WARNING Risk of infection A used test strip can transmit infections. Discard a used test strip as infectious material according to the regulations applicable in your country. For information on how to discard a used test strip correctly, contact your local council or authority. All components of the pack can be discarded in domestic waste.
14 Reporting of Serious Incidents For a patient/user/third party in the European Union and in countries with identical regulatory regime; if, during the use of this device or as a result of its use, a serious incident has occurred, please report it to the manufacturer and to your national authority.
15 Explanation of Symbols Symbol B W 2 e Description Consult instructions for use or consult electronic instructions for use Caution, refer to safety-related notes in the instructions for use accompanying this product. Temperature limit Use by (unopened or opened test strip container) b All components of the pack can be discarded in domestic waste. Discard used test strips according to local regulations.
16 References [1] D’Orazio et al.: Approved IFCC Recommendation on Reporting Results for Blood Glucose (Abbreviated); Clinical Chemistry 51:9, 1573–1576, 2005 [2] American Diabetes Association: 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes–2020. Diabetes Care 2020, 43, (Supplement 1): S14–S31 [3] IDF Clinical Guidelines Task Force. Global guideline for Type 2 diabetes.
Last update: 2021-07 IN VITRO DIAGNOSTIC MEDICAL DEVICE © 2021 Roche Diabetes Care M Roche Diabetes Care GmbH Sandhofer Strasse 116 68305 Mannheim, Germany www.accu-chek.com 09432019001(01) ACCU-CHEK and ACCU-CHEK SUGARVIEW are trademarks of Roche. All other product names and trademarks are the property of their respective owners.
